MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRATOME XL; SNARE, FLEXIBLE

Model Number	M00535900
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was attempted to be used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stricture performed on (b)(6) 2025.During the procedure, the tome was difficult to advance through the scope, and the handle was broken.A photo of the complaint device was provided where it can be observed that the handle was broken and the wire was detached.The procedure was completed with another ultratome xl.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was attempted to be used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stricture performed on (b)(6) 2025.During the procedure, the tome was difficult to advance through the scope, and the handle was broken.A photo of the complaint device was provided where it can be observed that the handle was broken and the wire was detached.The procedure was completed with another ultratome xl.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Block h11: investigation results: the ultratome xl device was not returned; however, a media analysis was performed based on the photo provided by the complainant where was possible to observe the handle broken, however, the cutting wire wasn't broken, additionally, by the picture, it is not possible to determine if the device was difficult to advance.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of cutting wire break was not confirmed.According to the media analysis performed, it was possible to observe the handle broken, however, the cutting wire was not broken.The most probable cause of the reported event cannot be established due to lack of evidence.The product was not returned for analysis to identify any defect with the device.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is cause not established.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.

• Brand Name: ULTRATOME XL
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23348577
• Report Number: 3005099803-2025-05564
• Device Sequence Number: 18094621
• Product Code: FDI
• UDI-Device Identifier: 08714729103257
• UDI-Public: (01)08714729103257(17)270120(10)35666248
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K930022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00535900
• Device Catalogue Number: M00535900
• Device Lot Number: 0035666248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/06/2025; 06/11/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/26/2025; 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female